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Drugs@FDA: FDA-Approved Drugs

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All Approvals and Tentative Approvals
September 2015

This report includes approvals of NDAs, BLAs, ANDAs, and approved supplements to those applications, and tentative ANDA/NDA approvals during the selected month. This report does not include BLAs/NDAs and supplements to those applications approved by CBER.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on November 28, 2023.

Approval Date Drug Name Submission Active Ingredients Company Submission Classification * Submission Status
09/01/2015 PREMARIN
NDA #004782		 SUPPL-173 ESTROGENS, CONJUGATED WYETH PHARMS Manufacturing (CMC) Approval
09/01/2015 DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-122 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-122 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-122 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-122 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-122 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-122 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-122 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-122 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-122 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-122 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-122 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-122 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-122 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-122 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #017512		 SUPPL-122 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 ACTHREL
BLA #020162		 SUPPL-10 CORTICORELIN OVINE TRIFLUTATE FERRING Approval
09/01/2015 DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #020163		 SUPPL-27 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #020163		 SUPPL-27 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #020163		 SUPPL-27 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
NDA #020183		 SUPPL-26 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
NDA #020183		 SUPPL-26 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
NDA #020183		 SUPPL-26 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
NDA #020183		 SUPPL-26 CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/01/2015 ESTRADIOL
NDA #020538		 SUPPL-33 ESTRADIOL SANDOZ Manufacturing (CMC) Approval
09/01/2015 VIVELLE-DOT
NDA #020538		 SUPPL-33 ESTRADIOL SANDOZ Manufacturing (CMC) Approval
09/01/2015 CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-31 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/01/2015 CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-31 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/01/2015 CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-31 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/01/2015 CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-31 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/01/2015 CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-31 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/01/2015 CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-31 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/01/2015 CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-31 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/01/2015 CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-31 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/01/2015 CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-31 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/01/2015 CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-31 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/01/2015 CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-31 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/01/2015 CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER
NDA #020678		 SUPPL-31 AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/01/2015 IMODIUM MULTI-SYMPTOM RELIEF
NDA #021140		 SUPPL-23 LOPERAMIDE HYDROCHLORIDE; SIMETHICONE J AND J CONSUMER INC Manufacturing (CMC) Approval
09/01/2015 CIALIS
NDA #021368		 SUPPL-25 TADALAFIL LILLY Manufacturing (CMC) Approval
09/01/2015 AMPICILLIN SODIUM
ANDA #061395		 SUPPL-37 AMPICILLIN SODIUM SANDOZ Labeling Approval
09/01/2015 E.E.S. 200
ANDA #061639		 SUPPL-33 ERYTHROMYCIN ETHYLSUCCINATE ARBOR PHARMS LLC Labeling Approval
09/01/2015 E.E.S. 400
ANDA #061639		 SUPPL-33 ERYTHROMYCIN ETHYLSUCCINATE ARBOR PHARMS LLC Labeling Approval
09/01/2015 E.E.S. 400
ANDA #061905		 SUPPL-50 ERYTHROMYCIN ETHYLSUCCINATE ARBOR PHARMS LLC Labeling Approval
09/01/2015 SENSORCAINE
ANDA #070552		 SUPPL-23 BUPIVACAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
09/01/2015 SENSORCAINE
ANDA #070553		 SUPPL-22 BUPIVACAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
09/01/2015 SENSORCAINE
ANDA #070554		 SUPPL-28 BUPIVACAINE HYDROCHLORIDE FRESENIUS KABI USA Labeling Approval
09/01/2015 SENSORCAINE
ANDA #070966		 SUPPL-28 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE FRESENIUS KABI USA Labeling Approval
09/01/2015 SENSORCAINE
ANDA #070967		 SUPPL-25 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE FRESENIUS KABI USA Labeling Approval
09/01/2015 SENSORCAINE
ANDA #070968		 SUPPL-25 BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE FRESENIUS KABI USA Labeling Approval
09/01/2015 SOTALOL HYDROCHLORIDE
ANDA #075237		 SUPPL-6 SOTALOL HYDROCHLORIDE MYLAN Labeling Approval
09/01/2015 SOTALOL HYDROCHLORIDE
ANDA #075237		 SUPPL-8 SOTALOL HYDROCHLORIDE MYLAN Labeling Approval
09/01/2015 ENALAPRIL MALEATE
ANDA #075483		 SUPPL-14 ENALAPRIL MALEATE WOCKHARDT LTD Labeling Approval
09/01/2015 ENALAPRIL MALEATE
ANDA #075483		 SUPPL-15 ENALAPRIL MALEATE WOCKHARDT LTD Labeling Approval
09/01/2015 GRANISETRON HYDROCHLORIDE
ANDA #079078		 SUPPL-3 GRANISETRON HYDROCHLORIDE AKORN Labeling Approval
09/01/2015 SUMATRIPTAN SUCCINATE
ANDA #090641		 SUPPL-1 SUMATRIPTAN SUCCINATE STERISCIENCE Labeling Approval
09/01/2015 SUMATRIPTAN SUCCINATE
ANDA #090641		 SUPPL-3 SUMATRIPTAN SUCCINATE STERISCIENCE Labeling Approval
09/01/2015 SUMATRIPTAN SUCCINATE
ANDA #090641		 SUPPL-4 SUMATRIPTAN SUCCINATE STERISCIENCE Labeling Approval
09/01/2015 LEVETIRACETAM
ANDA #090843		 SUPPL-3 LEVETIRACETAM ACCORD HLTHCARE Labeling Approval
09/01/2015 LEVETIRACETAM
ANDA #090843		 SUPPL-4 LEVETIRACETAM ACCORD HLTHCARE Labeling Approval
09/01/2015 LEVETIRACETAM
ANDA #090843		 SUPPL-6 LEVETIRACETAM ACCORD HLTHCARE Labeling Approval
09/01/2015 TOBRAMYCIN
ANDA #091589		 SUPPL-4 TOBRAMYCIN TEVA PHARMS USA Labeling Approval
09/01/2015 OXYCODONE HYDROCHLORIDE
NDA #200535		 SUPPL-10 OXYCODONE HYDROCHLORIDE GENUS LIFESCIENCES Manufacturing (CMC) Approval
09/01/2015 KALYDECO
NDA #203188		 SUPPL-18 IVACAFTOR VERTEX PHARMS Manufacturing (CMC) Approval
09/01/2015 XIGDUO XR
NDA #205649		 SUPPL-1 DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE ASTRAZENECA AB Manufacturing (CMC) Approval
09/01/2015 ZYDELIG
NDA #205858		 SUPPL-1 IDELALISIB GILEAD SCIENCES INC Manufacturing (CMC) Approval
09/01/2015 NAMZARIC
NDA #206439		 SUPPL-1 DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE ABBVIE Manufacturing (CMC) Approval
09/01/2015 VARUBI
NDA #206500		 ORIG-1 ROLAPITANT HYDROCHLORIDE TERSERA Type 1 - New Molecular Entity Approval
09/01/2015 BALSALAZIDE DISODIUM
ANDA #206909		 ORIG-1 BALSALAZIDE DISODIUM MYLAN PHARMS INC Tentative Approval
09/02/2015 TREANDA
NDA #022249		 SUPPL-21 BENDAMUSTINE HYDROCHLORIDE CEPHALON Labeling Approval
09/02/2015 COARTEM
NDA #022268		 SUPPL-13 ARTEMETHER; LUMEFANTRINE NOVARTIS Manufacturing (CMC) Approval
09/02/2015 TESTOSTERONE ENANTHATE
ANDA #040575		 SUPPL-9 TESTOSTERONE ENANTHATE NEXUS Labeling Approval
09/02/2015 DORYX
NDA #050582		 SUPPL-29 DOXYCYCLINE HYCLATE MAYNE PHARMA Labeling Approval
09/02/2015 PIROXICAM
ANDA #073536		 SUPPL-17 PIROXICAM SUN PHARM INDUSTRIES Labeling Approval
09/02/2015 GLYBURIDE (MICRONIZED)
ANDA #074686		 SUPPL-27 GLYBURIDE TEVA Labeling Approval
09/02/2015 NALTREXONE HYDROCHLORIDE
ANDA #074918		 SUPPL-17 NALTREXONE HYDROCHLORIDE BARR Labeling Approval
09/02/2015 NALTREXONE HYDROCHLORIDE
ANDA #074918		 SUPPL-18 NALTREXONE HYDROCHLORIDE BARR Labeling Approval
09/02/2015 NAPROXEN
ANDA #075227		 SUPPL-12 NAPROXEN TEVA Labeling Approval
09/02/2015 AZASAN
ANDA #075252		 SUPPL-17 AZATHIOPRINE AAIPHARMA LLC Labeling Approval
09/02/2015 AZASAN
ANDA #075252		 SUPPL-18 AZATHIOPRINE AAIPHARMA LLC Labeling Approval
09/02/2015 DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE
ANDA #076536		 SUPPL-5 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE BARR LABS INC Labeling Approval
09/02/2015 OXYBUTYNIN CHLORIDE
ANDA #076745		 SUPPL-14 OXYBUTYNIN CHLORIDE IMPAX PHARMS Labeling Approval
09/02/2015 OXYBUTYNIN CHLORIDE
ANDA #076745		 SUPPL-18 OXYBUTYNIN CHLORIDE IMPAX PHARMS Labeling Approval
09/02/2015 FINASTERIDE
ANDA #078161		 SUPPL-2 FINASTERIDE MYLAN Labeling Approval
09/02/2015 FAMOTIDINE
ANDA #090283		 SUPPL-2 FAMOTIDINE SUN PHARM INDS LTD Labeling Approval
09/02/2015 AMPICILLIN AND SULBACTAM
ANDA #090375		 SUPPL-1 AMPICILLIN SODIUM; SULBACTAM SODIUM HOSPIRA INC Labeling Approval
09/02/2015 AMPICILLIN AND SULBACTAM
ANDA #090375		 SUPPL-3 AMPICILLIN SODIUM; SULBACTAM SODIUM HOSPIRA INC Labeling Approval
09/02/2015 AMPICILLIN AND SULBACTAM
ANDA #090646		 SUPPL-1 AMPICILLIN SODIUM; SULBACTAM SODIUM HOSPIRA INC Labeling Approval
09/02/2015 AMPICILLIN AND SULBACTAM
ANDA #090646		 SUPPL-3 AMPICILLIN SODIUM; SULBACTAM SODIUM HOSPIRA INC Labeling Approval
09/02/2015 AMPICILLIN AND SULBACTAM
ANDA #090653		 SUPPL-1 AMPICILLIN SODIUM; SULBACTAM SODIUM HOSPIRA INC Labeling Approval
09/02/2015 AMPICILLIN AND SULBACTAM
ANDA #090653		 SUPPL-3 AMPICILLIN SODIUM; SULBACTAM SODIUM HOSPIRA INC Labeling Approval
09/02/2015 IBANDRONATE SODIUM
ANDA #090853		 SUPPL-3 IBANDRONATE SODIUM SUN PHARM Labeling Approval
09/02/2015 ZOLEDRONIC ACID
ANDA #091363		 SUPPL-4 ZOLEDRONIC ACID DR REDDYS LABS LTD Labeling Approval
09/02/2015 IBANDRONATE SODIUM
ANDA #202671		 SUPPL-1 IBANDRONATE SODIUM MYLAN LABS LTD Labeling Approval
09/02/2015 VORICONAZOLE
ANDA #203503		 ORIG-1 VORICONAZOLE GLENMARK PHARMS LTD Approval
09/02/2015 IBANDRONATE SODIUM
ANDA #203987		 SUPPL-3 IBANDRONATE SODIUM AVET LIFESCIENCES Labeling Approval
09/02/2015 OMTRYG
NDA #204977		 SUPPL-4 OMEGA-3-ACID ETHYL ESTERS TYPE A OSMOTICA PHARM US Manufacturing (CMC) Approval
09/02/2015 CETIRIZINE HYDROCHLORIDE ALLERGY
ANDA #205490		 ORIG-1 CETIRIZINE HYDROCHLORIDE PERRIGO R AND D Approval
09/02/2015 STERILE WATER FOR INJECTION
ANDA #206369		 ORIG-1 STERILE WATER FOR INJECTION HIKMA Approval
09/02/2015 FLUOCINOLONE ACETONIDE
ANDA #206422		 ORIG-1 FLUOCINOLONE ACETONIDE LUPIN Approval
09/02/2015 AVYCAZ
NDA #206494		 SUPPL-1 AVIBACTAM SODIUM; CEFTAZIDIME ALLERGAN Labeling Approval
09/03/2015 TENORMIN
NDA #018240		 SUPPL-38 ATENOLOL ALMATICA Manufacturing (CMC) Approval
09/03/2015 ESTROSTEP 21
NDA #020130		 SUPPL-14 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Manufacturing (CMC) Approval
09/03/2015 ESTROSTEP FE
NDA #020130		 SUPPL-14 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Manufacturing (CMC) Approval
09/03/2015 LANOXIN
NDA #020405		 SUPPL-12 DIGOXIN CONCORDIA Manufacturing (CMC) Approval
09/03/2015 ANGIOMAX
NDA #020873		 SUPPL-35 BIVALIRUDIN SANDOZ Manufacturing (CMC) Approval
09/03/2015 FEMCON FE
NDA #021490		 SUPPL-15 ETHINYL ESTRADIOL; NORETHINDRONE APIL Manufacturing (CMC) Approval
09/03/2015 IMPLANON
NDA #021529		 SUPPL-12 ETONOGESTREL ORGANON Manufacturing (CMC) Approval
09/03/2015 NEXPLANON
NDA #021529		 SUPPL-12 ETONOGESTREL ORGANON Manufacturing (CMC) Approval
09/03/2015 ACZONE
NDA #021794		 SUPPL-14 DAPSONE ABBVIE Manufacturing (CMC) Approval
09/03/2015 ABSORICA
NDA #021951		 SUPPL-5 ISOTRETINOIN SUN PHARM INDS INC REMS Approval
09/03/2015 BRILINTA
NDA #022433		 SUPPL-15 TICAGRELOR ASTRAZENECA Efficacy Approval
09/03/2015 ORACEA
NDA #050805		 SUPPL-10 DOXYCYCLINE GALDERMA LABS LP Manufacturing (CMC) Approval
09/03/2015 GLYBURIDE
ANDA #074388		 SUPPL-46 GLYBURIDE TEVA Labeling Approval
09/03/2015 AMNESTEEM
ANDA #075945		 SUPPL-31 ISOTRETINOIN MYLAN PHARMS INC Labeling Approval
09/03/2015 CLARAVIS
ANDA #076135		 SUPPL-35 ISOTRETINOIN TEVA PHARMS USA REMS Approval
09/03/2015 CLARAVIS
ANDA #076356		 SUPPL-32 ISOTRETINOIN TEVA PHARMS USA REMS Approval
09/03/2015 MYORISAN
ANDA #076485		 SUPPL-10 ISOTRETINOIN UPSHER SMITH LABS REMS Approval
09/03/2015 LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ANDA #078579		 ORIG-1 LEVOFLOXACIN HOSPIRA Approval
09/03/2015 ESCITALOPRAM OXALATE
ANDA #078766		 SUPPL-3 ESCITALOPRAM OXALATE HIKMA PHARMS Labeling Approval
09/03/2015 ESCITALOPRAM OXALATE
ANDA #078766		 SUPPL-4 ESCITALOPRAM OXALATE HIKMA PHARMS Labeling Approval
09/03/2015 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
ANDA #090979		 SUPPL-4 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE PADAGIS ISRAEL Labeling Approval
09/03/2015 GUAIFENESIN
ANDA #091009		 ORIG-1 GUAIFENESIN ACTAVIS LABS FL Approval
09/03/2015 ZOLEDRONIC ACID
ANDA #091493		 SUPPL-1 ZOLEDRONIC ACID SAGENT PHARMS INC Labeling Approval
09/03/2015 ZOLEDRONIC ACID
ANDA #091493		 SUPPL-4 ZOLEDRONIC ACID SAGENT PHARMS INC Labeling Approval
09/03/2015 HYDROMORPHONE HYDROCHLORIDE
NDA #200403		 SUPPL-5 HYDROMORPHONE HYDROCHLORIDE HOSPIRA INC Manufacturing (CMC) Approval
09/03/2015 ZENATANE
ANDA #202099		 SUPPL-4 ISOTRETINOIN DR REDDYS LABS LTD REMS Approval
09/03/2015 FYCOMPA
NDA #202834		 SUPPL-8 PERAMPANEL CATALYST PHARMS Manufacturing (CMC) Approval
09/03/2015 MINASTRIN 24 FE
NDA #203667		 SUPPL-5 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE APIL Manufacturing (CMC) Approval
09/03/2015 RIVASTIGMINE
ANDA #204403		 ORIG-2 RIVASTIGMINE ALVOGEN Approval
09/03/2015 TELMISARTAN
ANDA #206511		 ORIG-1 TELMISARTAN AUROBINDO PHARMA Approval
09/04/2015 MECLOFENAMATE SODIUM
ANDA #071081		 SUPPL-18 MECLOFENAMATE SODIUM MYLAN Labeling Approval
09/04/2015 ZONISAMIDE
ANDA #077642		 SUPPL-5 ZONISAMIDE APOTEX INC Labeling Approval
09/04/2015 ZONISAMIDE
ANDA #077642		 SUPPL-6 ZONISAMIDE APOTEX INC Labeling Approval
09/04/2015 MEMANTINE HYDROCHLORIDE
ANDA #090073		 ORIG-1 MEMANTINE HYDROCHLORIDE CELLTRION Approval
09/04/2015 QUETIAPINE FUMARATE
ANDA #090749		 SUPPL-2 QUETIAPINE FUMARATE HIKMA Labeling Approval
09/04/2015 QUETIAPINE FUMARATE
ANDA #090749		 SUPPL-4 QUETIAPINE FUMARATE HIKMA Labeling Approval
09/04/2015 DURLAZA
NDA #200671		 ORIG-1 ASPIRIN ESPERO Type 3 - New Dosage Form Approval
09/04/2015 LEVETIRACETAM
ANDA #202167		 ORIG-1 LEVETIRACETAM DEXCEL Approval
09/04/2015 ZIOPTAN
NDA #202514		 SUPPL-3 TAFLUPROST THEA PHARMA Manufacturing (CMC) Approval
09/04/2015 ZIOPTAN
NDA #202514		 SUPPL-4 TAFLUPROST THEA PHARMA Labeling Approval
09/04/2015 AMPICILLIN SODIUM
ANDA #202864		 ORIG-1 AMPICILLIN SODIUM HOSPIRA Approval
09/04/2015 AMPICILLIN SODIUM
ANDA #202865		 ORIG-1 AMPICILLIN SODIUM HOSPIRA Approval
09/04/2015 MONTELUKAST SODIUM
ANDA #204604		 ORIG-1 MONTELUKAST SODIUM AMNEAL PHARMS Approval
09/04/2015 DESOXIMETASONE
ANDA #205082		 ORIG-1 DESOXIMETASONE ACTAVIS MID ATLANTIC Approval
09/04/2015 XURIDEN
NDA #208169		 ORIG-1 URIDINE TRIACETATE BTG INTL Type 1 - New Molecular Entity Approval
09/08/2015 NIFEDIPINE
ANDA #075289		 SUPPL-10 NIFEDIPINE VALEANT PHARMS NORTH Labeling Approval
09/08/2015 METOPROLOL TARTRATE
ANDA #077739		 SUPPL-13 METOPROLOL TARTRATE AUROBINDO PHARMA Labeling Approval
09/08/2015 TESTOSTERONE ENANTHATE
ANDA #091120		 SUPPL-3 TESTOSTERONE ENANTHATE HIKMA FARMACEUTICA Labeling Approval
09/08/2015 TELMISARTAN
ANDA #204415		 ORIG-1 TELMISARTAN AMNEAL PHARMS Approval
09/08/2015 BALSALAZIDE DISODIUM
ANDA #206336		 ORIG-1 BALSALAZIDE DISODIUM STRIDES PHARMA Approval
09/09/2015 CILOXAN
NDA #020369		 SUPPL-20 CIPROFLOXACIN HYDROCHLORIDE SANDOZ Manufacturing (CMC) Approval
09/09/2015 LOPERAMIDE HYDROCHLORIDE
ANDA #076497		 SUPPL-2 LOPERAMIDE HYDROCHLORIDE LNK Labeling Approval
09/09/2015 VANCOMYCIN HYDROCHLORIDE
ANDA #091377		 ORIG-1 VANCOMYCIN HYDROCHLORIDE XELLIA PHARMS APS Approval
09/09/2015 HUMIRA
BLA #125057		 SUPPL-393 ADALIMUMAB ABBVIE INC Approval
09/09/2015 NORGESTIMATE AND ETHINYL ESTRADIOL
ANDA #202132		 ORIG-1 ETHINYL ESTRADIOL; NORGESTIMATE MYLAN LABS LTD Approval
09/09/2015 ESCITALOPRAM OXALATE
ANDA #202210		 SUPPL-7 ESCITALOPRAM OXALATE MACLEODS PHARMS LTD Labeling Approval
09/09/2015 PROCYSBI
NDA #203389		 SUPPL-13 CYSTEAMINE BITARTRATE HORIZON Manufacturing (CMC) Approval
09/09/2015 INVOKANA
NDA #204042		 SUPPL-9 CANAGLIFLOZIN JANSSEN PHARMS Manufacturing (CMC) Approval
09/09/2015 DELZICOL
NDA #204412		 SUPPL-6 MESALAMINE ABBVIE Efficacy Approval
09/09/2015 FERRIPROX
NDA #208030		 ORIG-1 DEFERIPRONE CHIESI Type 3 - New Dosage Form Approval
09/10/2015 CHORIONIC GONADOTROPIN
BLA #017067		 SUPPL-62 GONADOTROPIN, CHORIONIC FRESENIUS KABI USA Approval
09/10/2015 TECHNETIUM TC-99M MEDRONATE KIT
NDA #018107		 SUPPL-14 TECHNETIUM TC-99M MEDRONATE KIT CARDINAL HEALTH 414 Manufacturing (CMC) Approval
09/10/2015 TENORMIN
NDA #018240		 SUPPL-39 ATENOLOL ALMATICA Manufacturing (CMC) Approval
09/10/2015 NICORETTE
NDA #018612		 SUPPL-77 NICOTINE POLACRILEX GLAXOSMITHKLINE Manufacturing (CMC) Approval
09/10/2015 NICORETTE (MINT)
NDA #018612		 SUPPL-77 NICOTINE POLACRILEX GLAXOSMITHKLINE Manufacturing (CMC) Approval
09/10/2015 CHOLETEC
NDA #018963		 SUPPL-9 TECHNETIUM TC-99M MEBROFENIN KIT BRACCO Manufacturing (CMC) Approval
09/10/2015 POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019686		 SUPPL-32 POTASSIUM CHLORIDE; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
09/10/2015 POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019686		 SUPPL-32 POTASSIUM CHLORIDE; SODIUM CHLORIDE ICU MEDICAL INC Manufacturing (CMC) Approval
09/10/2015 CONDYLOX
NDA #019795		 SUPPL-15 PODOFILOX TEVA BRANDED PHARM Manufacturing (CMC) Approval
09/10/2015 SALAGEN
NDA #020237		 SUPPL-21 PILOCARPINE HYDROCHLORIDE CONCORDIA Manufacturing (CMC) Approval
09/10/2015 GENOTROPIN
BLA #020280		 SUPPL-81 SOMATROPIN PHARMACIA Approval
09/10/2015 GENOTROPIN PRESERVATIVE FREE
BLA #020280		 SUPPL-81 SOMATROPIN PHARMACIA Approval
09/10/2015 FAMVIR
NDA #020363		 SUPPL-46 FAMCICLOVIR NOVARTIS Manufacturing (CMC) Approval
09/10/2015 HUMALOG
BLA #020563		 SUPPL-161 INSULIN LISPRO RECOMBINANT LILLY Approval
09/10/2015 HUMALOG KWIKPEN
BLA #020563		 SUPPL-161 INSULIN LISPRO RECOMBINANT LILLY Approval
09/10/2015 HUMALOG PEN
BLA #020563		 SUPPL-161 INSULIN LISPRO RECOMBINANT LILLY Approval
09/10/2015 HUMALOG TEMPO PEN
BLA #020563		 SUPPL-161 INSULIN LISPRO RECOMBINANT LILLY Approval
09/10/2015 CYCLESSA
NDA #021090		 SUPPL-7 DESOGESTREL; ETHINYL ESTRADIOL ASPEN GLOBAL INC Manufacturing (CMC) Approval
09/10/2015 FOLLISTIM AQ
BLA #021273		 SUPPL-11 FOLLITROPIN ALFA/BETA ORGANON USA INC Approval
09/10/2015 BRAVELLE
BLA #021289		 SUPPL-25 UROFOLLITROPIN FERRING Approval
09/10/2015 NEUPRO
NDA #021829		 SUPPL-9 ROTIGOTINE UCB INC Manufacturing (CMC) Approval
09/10/2015 FLUDEOXYGLUCOSE F18
NDA #021870		 SUPPL-11 FLUDEOXYGLUCOSE F-18 FEINSTEIN Manufacturing (CMC) Approval
09/10/2015 DICLEGIS
NDA #021876		 SUPPL-8 DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE DUCHESNAY Manufacturing (CMC) Approval
09/10/2015 CHILDREN'S ZYRTEC ALLERGY
NDA #022155		 SUPPL-11 CETIRIZINE HYDROCHLORIDE J AND J CONSUMER INC Manufacturing (CMC) Approval
09/10/2015 CHILDREN'S ZYRTEC HIVES RELIEF
NDA #022155		 SUPPL-11 CETIRIZINE HYDROCHLORIDE J AND J CONSUMER INC Manufacturing (CMC) Approval
09/10/2015 OXYCONTIN
NDA #022272		 SUPPL-29 OXYCODONE HYDROCHLORIDE PURDUE PHARMA LP Manufacturing (CMC) Approval
09/10/2015 APTIOM
NDA #022416		 SUPPL-4 ESLICARBAZEPINE ACETATE SUMITOMO PHARMA AM Manufacturing (CMC) Approval
09/10/2015 PRADAXA
NDA #022512		 SUPPL-27 DABIGATRAN ETEXILATE MESYLATE BOEHRINGER INGELHEIM Labeling Approval
09/10/2015 KARBINAL ER
NDA #022556		 SUPPL-1 CARBINOXAMINE MALEATE AYTU Manufacturing (CMC) Approval
09/10/2015 DOXORUBICIN HYDROCHLORIDE
NDA #050467		 SUPPL-75 DOXORUBICIN HYDROCHLORIDE PFIZER Manufacturing (CMC) Approval
09/10/2015 TOBREX
NDA #050555		 SUPPL-35 TOBRAMYCIN NOVARTIS Manufacturing (CMC) Approval
09/10/2015 ACANYA
NDA #050819		 SUPPL-13 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE BAUSCH Manufacturing (CMC) Approval
09/10/2015 ONEXTON
NDA #050819		 SUPPL-13 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE BAUSCH Manufacturing (CMC) Approval
09/10/2015 AMOXICILLIN
ANDA #061926		 SUPPL-121 AMOXICILLIN TEVA Labeling Approval
09/10/2015 AMOXICILLIN
ANDA #061931		 SUPPL-42 AMOXICILLIN TEVA Labeling Approval
09/10/2015 AMOXICILLIN PEDIATRIC
ANDA #061931		 SUPPL-42 AMOXICILLIN TEVA Labeling Approval
09/10/2015 DOXYCYCLINE HYCLATE
ANDA #062676		 SUPPL-42 DOXYCYCLINE HYCLATE SUN PHARM INDUSTRIES Labeling Approval
09/10/2015 DOXYCYCLINE HYCLATE
ANDA #062677		 SUPPL-41 DOXYCYCLINE HYCLATE SUN PHARM INDUSTRIES Labeling Approval
09/10/2015 UNASYN
ANDA #062901		 SUPPL-27 AMPICILLIN SODIUM; SULBACTAM SODIUM PFIZER Labeling Approval
09/10/2015 UNASYN
ANDA #062901		 SUPPL-28 AMPICILLIN SODIUM; SULBACTAM SODIUM PFIZER Labeling Approval
09/10/2015 AMOXICILLIN
ANDA #064013		 SUPPL-49 AMOXICILLIN TEVA Labeling Approval
09/10/2015 BETAXOLOL HYDROCHLORIDE
ANDA #075446		 SUPPL-16 BETAXOLOL HYDROCHLORIDE APOTEX INC Labeling Approval
09/10/2015 GLIPIZIDE
ANDA #076467		 SUPPL-19 GLIPIZIDE WATSON LABS Labeling Approval
09/10/2015 MIRTAZAPINE
ANDA #076901		 SUPPL-13 MIRTAZAPINE IMPAX LABS INC Labeling Approval
09/10/2015 GABAPENTIN
ANDA #077242		 SUPPL-18 GABAPENTIN SUN PHARM INDS LTD Labeling Approval
09/10/2015 GABAPENTIN
ANDA #077525		 SUPPL-19 GABAPENTIN SUN PHARM INDS LTD Labeling Approval
09/10/2015 MELOXICAM
ANDA #077921		 SUPPL-17 MELOXICAM ZYDUS PHARMS USA Labeling Approval
09/10/2015 MELOXICAM
ANDA #077921		 SUPPL-18 MELOXICAM ZYDUS PHARMS USA Labeling Approval
09/10/2015 MELOXICAM
ANDA #077921		 SUPPL-21 MELOXICAM ZYDUS PHARMS USA Labeling Approval
09/10/2015 OXALIPLATIN
ANDA #078812		 SUPPL-3 OXALIPLATIN SANDOZ Labeling Approval
09/10/2015 OXALIPLATIN
ANDA #078812		 SUPPL-6 OXALIPLATIN SANDOZ Labeling Approval
09/10/2015 OXALIPLATIN
ANDA #091358		 SUPPL-2 OXALIPLATIN MYLAN LABS LTD Labeling Approval
09/10/2015 NARATRIPTAN
ANDA #091441		 SUPPL-1 NARATRIPTAN HYDROCHLORIDE ORBION PHARMS Labeling Approval
09/10/2015 ACITRETIN
ANDA #202148		 ORIG-1 ACITRETIN MYLAN Approval
09/10/2015 ELIQUIS
NDA #202155		 SUPPL-11 APIXABAN BRISTOL MYERS SQUIBB Labeling Approval
09/10/2015 XARELTO
NDA #202439		 SUPPL-15 RIVAROXABAN JANSSEN PHARMS Labeling Approval
09/10/2015 ACITRETIN
ANDA #203707		 ORIG-1 ACITRETIN MYLAN Approval
09/10/2015 XOFIGO
NDA #203971		 SUPPL-6 RADIUM RA-223 DICHLORIDE BAYER HLTHCARE Manufacturing (CMC) Approval
09/10/2015 INVOKANA
NDA #204042		 SUPPL-6 CANAGLIFLOZIN JANSSEN PHARMS Efficacy Approval
09/10/2015 TOPICORT
NDA #204141		 SUPPL-2 DESOXIMETASONE TARO PHARMS Manufacturing (CMC) Approval
09/10/2015 INVOKAMET
NDA #204353		 SUPPL-3 CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE JANSSEN PHARMS Efficacy Approval
09/10/2015 SAVAYSA
NDA #206316		 SUPPL-2 EDOXABAN TOSYLATE DAIICHI SANKYO INC Labeling Approval
09/10/2015 TRIFERIC
NDA #206317		 SUPPL-2 FERRIC PYROPHOSPHATE CITRATE ROCKWELL MEDICAL INC Manufacturing (CMC) Approval
09/11/2015 ACCUPRIL
NDA #019885		 SUPPL-41 QUINAPRIL HYDROCHLORIDE PFIZER PHARMS Labeling Approval
09/11/2015 ALTACE
NDA #019901		 SUPPL-65 RAMIPRIL KING PHARMS LLC Labeling Approval
09/11/2015 ACCURETIC
NDA #020125		 SUPPL-20 HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE PFIZER PHARMS Labeling Approval
09/11/2015 INTERMEZZO
NDA #022328		 SUPPL-4 ZOLPIDEM TARTRATE PURDUE PHARMA Labeling Approval
09/11/2015 DATSCAN
NDA #022454		 SUPPL-4 IOFLUPANE I-123 GE HLTHCARE INC Labeling Approval
09/11/2015 EXPAREL
NDA #022496		 SUPPL-15 BUPIVACAINE PACIRA PHARMS INC Manufacturing (CMC) Approval
09/11/2015 GENTAMICIN SULFATE
ANDA #062356		 SUPPL-24 GENTAMICIN SULFATE FRESENIUS KABI USA Labeling Approval
09/11/2015 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ANDA #075502		 SUPPL-14 BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE FOUGERA PHARMS Labeling Approval
09/11/2015 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
ANDA #075502		 SUPPL-15 BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE FOUGERA PHARMS Labeling Approval
09/11/2015 TICLOPIDINE HYDROCHLORIDE
ANDA #075526		 SUPPL-11 TICLOPIDINE HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
09/11/2015 HALOPERIDOL
ANDA #076035		 SUPPL-21 HALOPERIDOL LACTATE TEVA PHARMS USA Labeling Approval
09/11/2015 FENTANYL-100
ANDA #077449		 SUPPL-16 FENTANYL AVEVA Approval
09/11/2015 FENTANYL-12
ANDA #077449		 SUPPL-16 FENTANYL AVEVA Approval
09/11/2015 FENTANYL-25
ANDA #077449		 SUPPL-16 FENTANYL AVEVA Approval
09/11/2015 FENTANYL-37
ANDA #077449		 SUPPL-16 FENTANYL AVEVA Approval
09/11/2015 FENTANYL-50
ANDA #077449		 SUPPL-16 FENTANYL AVEVA Approval
09/11/2015 FENTANYL-62
ANDA #077449		 SUPPL-16 FENTANYL AVEVA Approval
09/11/2015 FENTANYL-75
ANDA #077449		 SUPPL-16 FENTANYL AVEVA Approval
09/11/2015 FENTANYL-87
ANDA #077449		 SUPPL-16 FENTANYL AVEVA Approval
09/11/2015 BUPROPION HYDROCHLORIDE
ANDA #090325		 SUPPL-10 BUPROPION HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
09/11/2015 BUPROPION HYDROCHLORIDE
ANDA #090325		 SUPPL-12 BUPROPION HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
09/11/2015 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090781		 SUPPL-2 PRAMIPEXOLE DIHYDROCHLORIDE GLENMARK GENERICS Manufacturing (CMC) Approval
09/11/2015 TOBI PODHALER
NDA #201688		 SUPPL-5 TOBRAMYCIN MYLAN SPECIALITY LP Manufacturing (CMC) Approval
09/11/2015 FLUVASTATIN SODIUM
ANDA #202458		 ORIG-1 FLUVASTATIN SODIUM MYLAN Approval
09/11/2015 ZOLEDRONIC ACID
ANDA #202746		 SUPPL-3 ZOLEDRONIC ACID SUN PHARMA GLOBAL Labeling Approval
09/11/2015 SUMATRIPTAN SUCCINATE
ANDA #202758		 SUPPL-3 SUMATRIPTAN SUCCINATE EUGIA PHARMA Labeling Approval
09/11/2015 OXTELLAR XR
NDA #202810		 SUPPL-4 OXCARBAZEPINE SUPERNUS PHARMS Manufacturing (CMC) Approval
09/11/2015 ZOLEDRONIC ACID
ANDA #202923		 SUPPL-3 ZOLEDRONIC ACID USV Labeling Approval
09/11/2015 ZOLEDRONIC ACID
ANDA #202923		 SUPPL-5 ZOLEDRONIC ACID USV Labeling Approval
09/11/2015 FLUDEOXYGLUCOSE F18
ANDA #204472		 ORIG-1 FLUDEOXYGLUCOSE F-18 MIPS CRF Approval
09/11/2015 NEVIRAPINE
ANDA #204621		 ORIG-2 NEVIRAPINE ALVOGEN Approval
09/13/2015 THALOMID
NDA #020785		 SUPPL-57 THALIDOMIDE BRISTOL-MYERS SQUIBB CO REMS Approval
09/13/2015 REVLIMID
NDA #021880		 SUPPL-44 LENALIDOMIDE BRISTOL MYERS SQUIBB REMS Approval
09/14/2015 CLARITIN
NDA #019658		 SUPPL-43 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
09/14/2015 CLARITIN HIVES RELIEF
NDA #019658		 SUPPL-43 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
09/14/2015 NEURONTIN
NDA #020235		 SUPPL-60 GABAPENTIN VIATRIS Labeling Approval
09/14/2015 NEURONTIN
NDA #020882		 SUPPL-43 GABAPENTIN VIATRIS Labeling Approval
09/14/2015 TARGRETIN
NDA #021055		 SUPPL-11 BEXAROTENE VALEANT LUXEMBOURG Manufacturing (CMC) Approval
09/14/2015 NEURONTIN
NDA #021129		 SUPPL-42 GABAPENTIN VIATRIS Labeling Approval
09/14/2015 ALTOPREV
NDA #021316		 SUPPL-33 LOVASTATIN COVIS Manufacturing (CMC) Approval
09/14/2015 VELCADE
NDA #021602		 SUPPL-42 BORTEZOMIB TAKEDA PHARMS USA Efficacy Approval
09/14/2015 CLOZAPINE
ANDA #074949		 SUPPL-66 CLOZAPINE IVAX SUB TEVA PHARMS Labeling Approval
09/14/2015 CLOZAPINE
ANDA #075417		 SUPPL-36 CLOZAPINE MYLAN Labeling Approval
09/14/2015 CLOZAPINE
ANDA #076809		 SUPPL-29 CLOZAPINE IVAX SUB TEVA PHARMS Labeling Approval
09/14/2015 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
ANDA #090228		 SUPPL-2 FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE INVAGEN PHARMS Labeling Approval
09/14/2015 FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
ANDA #090228		 SUPPL-3 FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE INVAGEN PHARMS Labeling Approval
09/14/2015 NARATRIPTAN
ANDA #090381		 SUPPL-2 NARATRIPTAN HYDROCHLORIDE HIKMA Labeling Approval
09/14/2015 NARATRIPTAN
ANDA #091373		 SUPPL-3 NARATRIPTAN HYDROCHLORIDE APOTEX CORP Labeling Approval
09/14/2015 XALKORI
NDA #202570		 SUPPL-14 CRIZOTINIB PF PRISM CV Efficacy Approval
09/14/2015 POMALYST
NDA #204026		 SUPPL-9 POMALIDOMIDE BRISTOL REMS Approval
09/15/2015 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-38 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
09/15/2015 SODIUM CHLORIDE 0.9%
NDA #019635		 SUPPL-38 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
09/15/2015 SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-38 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
09/15/2015 SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-38 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
09/15/2015 SODIUM CHLORIDE 5% IN PLASTIC CONTAINER
NDA #019635		 SUPPL-38 SODIUM CHLORIDE B BRAUN Manufacturing (CMC) Approval
09/15/2015 CLOZARIL
NDA #019758		 SUPPL-61 CLOZAPINE HERITAGE LIFE REMS Approval
09/15/2015 CLOZARIL
NDA #019758		 SUPPL-77 CLOZAPINE HERITAGE LIFE Labeling Approval
09/15/2015 FAZACLO ODT
NDA #021590		 SUPPL-14 CLOZAPINE JAZZ REMS Approval
09/15/2015 FAZACLO ODT
NDA #021590		 SUPPL-27 CLOZAPINE JAZZ Labeling Approval
09/15/2015 OSMOPREP
NDA #021892		 SUPPL-12 SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE SALIX PHARMS Manufacturing (CMC) Approval
09/15/2015 CLOZAPINE
ANDA #074949		 SUPPL-67 CLOZAPINE IVAX SUB TEVA PHARMS REMS Approval
09/15/2015 CLOZAPINE
ANDA #075417		 SUPPL-37 CLOZAPINE MYLAN REMS Approval
09/15/2015 HALOPERIDOL
ANDA #075689		 SUPPL-15 HALOPERIDOL LACTATE FRESENIUS KABI USA Labeling Approval
09/15/2015 HALOPERIDOL
ANDA #075689		 SUPPL-19 HALOPERIDOL LACTATE FRESENIUS KABI USA Labeling Approval
09/15/2015 CLOZAPINE
ANDA #075713		 SUPPL-36 CLOZAPINE SUN PHARM INDS INC REMS Approval
09/15/2015 CLOZAPINE
ANDA #076809		 SUPPL-30 CLOZAPINE IVAX SUB TEVA PHARMS REMS Approval
09/15/2015 GEMFIBROZIL
ANDA #079072		 SUPPL-5 GEMFIBROZIL NORTHSTAR HLTHCARE Labeling Approval
09/15/2015 GEMFIBROZIL
ANDA #079072		 SUPPL-6 GEMFIBROZIL NORTHSTAR HLTHCARE Labeling Approval
09/15/2015 IBUPROFEN
ANDA #091625		 ORIG-1 IBUPROFEN GRANULES Approval
09/15/2015 DURLAZA
NDA #200671		 SUPPL-1 ASPIRIN ESPERO Labeling Approval
09/15/2015 CLOZAPINE
ANDA #201824		 ORIG-1 CLOZAPINE MYLAN Approval
09/15/2015 CLOZAPINE
ANDA #201824		 ORIG-2 CLOZAPINE MYLAN Tentative Approval
09/15/2015 CLARITHROMYCIN
ANDA #202532		 ORIG-1 CLARITHROMYCIN LUPIN LTD Approval
09/15/2015 PYRIDOSTIGMINE BROMIDE
ANDA #203184		 ORIG-1 PYRIDOSTIGMINE BROMIDE IMPAX LABS INC Approval
09/15/2015 VERSACLOZ
NDA #203479		 SUPPL-7 CLOZAPINE TASMAN PHARMA Labeling Approval
09/15/2015 VERSACLOZ
NDA #203479		 SUPPL-8 CLOZAPINE TASMAN PHARMA REMS Approval
09/15/2015 BREO ELLIPTA
NDA #204275		 SUPPL-4 FLUTICASONE FUROATE; VILANTEROL TRIFENATATE GLAXO GRP LTD Labeling Approval
09/15/2015 APTENSIO XR
NDA #205831		 SUPPL-2 METHYLPHENIDATE HYDROCHLORIDE RHODES PHARMS Manufacturing (CMC) Approval
09/15/2015 SPIRIVA RESPIMAT
NDA #207070		 ORIG-1 TIOTROPIUM BROMIDE BOEHRINGER INGELHEIM Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval Approval
09/16/2015 DEXTROSE 5% IN PLASTIC CONTAINER
NDA #016673		 SUPPL-150 DEXTROSE BAXTER HLTHCARE Manufacturing (CMC) Approval
09/16/2015 ASACOL
NDA #019651		 SUPPL-26 MESALAMINE APIL Manufacturing (CMC) Approval
09/16/2015 MICROZIDE
NDA #020504		 SUPPL-23 HYDROCHLOROTHIAZIDE TEVA BRANDED PHARM Manufacturing (CMC) Approval
09/16/2015 VIAGRA
NDA #020895		 SUPPL-45 SILDENAFIL CITRATE VIATRIS Labeling Approval
09/16/2015 CIALIS
NDA #021368		 SUPPL-26 TADALAFIL LILLY Labeling Approval
09/16/2015 LEVITRA
NDA #021400		 SUPPL-19 VARDENAFIL HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
09/16/2015 BROVANA
NDA #021912		 SUPPL-26 ARFORMOTEROL TARTRATE LUPIN Manufacturing (CMC) Approval
09/16/2015 BRILINTA
NDA #022433		 SUPPL-16 TICAGRELOR ASTRAZENECA Manufacturing (CMC) Approval
09/16/2015 AFREZZA
BLA #022472		 SUPPL-4 INSULIN RECOMBINANT HUMAN MANNKIND Approval
09/16/2015 ZADITOR
ANDA #077200		 SUPPL-2 KETOTIFEN FUMARATE ALCON PHARMS LTD Labeling Approval
09/16/2015 PRAVASTATIN SODIUM
ANDA #077751		 SUPPL-10 PRAVASTATIN SODIUM ZYDUS PHARMS USA Labeling Approval
09/16/2015 PRAVASTATIN SODIUM
ANDA #077751		 SUPPL-11 PRAVASTATIN SODIUM ZYDUS PHARMS USA Labeling Approval
09/16/2015 SOJOURN
ANDA #077867		 SUPPL-9 SEVOFLURANE PIRAMAL CRITICAL Labeling Approval
09/16/2015 SOJOURN
ANDA #077867		 SUPPL-11 SEVOFLURANE PIRAMAL CRITICAL Labeling Approval
09/16/2015 SOJOURN
ANDA #077867		 SUPPL-12 SEVOFLURANE PIRAMAL CRITICAL Labeling Approval
09/16/2015 EPLERENONE
ANDA #078510		 SUPPL-9 EPLERENONE SANDOZ Labeling Approval
09/16/2015 BETAMETHASONE DIPROPIONATE
ANDA #078930		 SUPPL-6 BETAMETHASONE DIPROPIONATE GLENMARK GENERICS Labeling Approval
09/16/2015 DOXYCYCLINE HYCLATE
ANDA #090431		 SUPPL-8 DOXYCYCLINE HYCLATE RISING Labeling Approval
09/16/2015 FLUVOXAMINE MALEATE
ANDA #091476		 SUPPL-6 FLUVOXAMINE MALEATE ANCHEN PHARMS Labeling Approval
09/16/2015 PEGINTRON
BLA #103949		 SUPPL-5299 PEGINTERFERON ALFA-2B SCHERING Approval
09/16/2015 SYLATRON
BLA #103949		 SUPPL-5299 PEGINTERFERON ALFA-2B SCHERING Approval
09/16/2015 TRIBENZOR
NDA #200175		 SUPPL-23 AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL COSETTE Manufacturing (CMC) Approval
09/16/2015 STAXYN
NDA #200179		 SUPPL-3 VARDENAFIL HYDROCHLORIDE BAYER HLTHCARE Labeling Approval
09/16/2015 DICLOFENAC SODIUM AND MISOPROSTOL
ANDA #201089		 SUPPL-2 DICLOFENAC SODIUM; MISOPROSTOL ACTAVIS LABS FL INC Labeling Approval
09/16/2015 DICLOFENAC SODIUM AND MISOPROSTOL
ANDA #201089		 SUPPL-6 DICLOFENAC SODIUM; MISOPROSTOL ACTAVIS LABS FL INC Labeling Approval
09/16/2015 NADOLOL
ANDA #201893		 ORIG-1 NADOLOL AUROBINDO PHARMA Approval
09/16/2015 STENDRA
NDA #202276		 SUPPL-13 AVANAFIL METUCHEN PHARMS Labeling Approval
09/16/2015 NARATRIPTAN
ANDA #202431		 SUPPL-1 NARATRIPTAN HYDROCHLORIDE AUROBINDO PHARMA USA Labeling Approval
09/16/2015 GEMFIBROZIL
ANDA #202726		 ORIG-1 GEMFIBROZIL AUROBINDO PHARMA LTD Approval
09/16/2015 DOCETAXEL
ANDA #203877		 ORIG-1 DOCETAXEL TEVA PHARMS USA Approval
09/16/2015 FEXOFENADINE HYDROCHLORIDE ALLERGY
ANDA #204507		 ORIG-1 FEXOFENADINE HYDROCHLORIDE SCIEGEN PHARMS INC Approval
09/16/2015 FEXOFENADINE HYDROCHLORIDE HIVES
ANDA #204507		 ORIG-1 FEXOFENADINE HYDROCHLORIDE SCIEGEN PHARMS INC Approval
09/17/2015 CUBICIN
NDA #021572		 SUPPL-50 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
09/17/2015 CUBICIN RF
NDA #021572		 SUPPL-50 DAPTOMYCIN CUBIST PHARMS LLC Labeling Approval
09/17/2015 EPZICOM
NDA #021652		 SUPPL-19 ABACAVIR SULFATE; LAMIVUDINE VIIV HLTHCARE Efficacy Approval
09/17/2015 ZYPREXA RELPREVV
NDA #022173		 SUPPL-24 OLANZAPINE PAMOATE ELI LILLY CO Labeling Approval
09/17/2015 GABAPENTIN
ANDA #075360		 SUPPL-18 GABAPENTIN GRANULES Labeling Approval
09/17/2015 GABAPENTIN
ANDA #077661		 SUPPL-13 GABAPENTIN RUBICON Labeling Approval
09/17/2015 GABAPENTIN
ANDA #077894		 SUPPL-6 GABAPENTIN APOTEX INC Labeling Approval
09/17/2015 AMLODIPINE BESYLATE
ANDA #078021		 SUPPL-11 AMLODIPINE BESYLATE AUROBINDO PHARMA Labeling Approval
09/17/2015 VENLAFAXINE HYDROCHLORIDE
ANDA #078087		 SUPPL-3 VENLAFAXINE HYDROCHLORIDE ANCHEN PHARMS Labeling Approval
09/17/2015 VENLAFAXINE HYDROCHLORIDE
ANDA #078087		 SUPPL-5 VENLAFAXINE HYDROCHLORIDE ANCHEN PHARMS Labeling Approval
09/17/2015 VENLAFAXINE HYDROCHLORIDE
ANDA #078087		 SUPPL-7 VENLAFAXINE HYDROCHLORIDE ANCHEN PHARMS Labeling Approval
09/17/2015 LAMIVUDINE AND ZIDOVUDINE
ANDA #079124		 ORIG-1 LAMIVUDINE; ZIDOVUDINE HETERO LABS LTD III Approval
09/17/2015 ZALTRAP
BLA #125418		 SUPPL-33 ZIV-AFLIBERCEPT SANOFI AVENTIS US Approval
09/17/2015 ZOLMITRIPTAN
ANDA #202956		 ORIG-1 ZOLMITRIPTAN JUBILANT GENERICS Approval
09/17/2015 CLOZAPINE
ANDA #203807		 ORIG-1 CLOZAPINE DR REDDYS LABS SA Approval
09/17/2015 ADENOSINE
ANDA #203883		 SUPPL-1 ADENOSINE HOSPIRA Labeling Approval
09/17/2015 VRAYLAR
NDA #204370		 ORIG-1 CARIPRAZINE HYDROCHLORIDE ABBVIE Type 1 - New Molecular Entity Approval
09/17/2015 VRAYLAR
NDA #204370		 ORIG-2 CARIPRAZINE HYDROCHLORIDE ABBVIE Efficacy Approval
09/18/2015 AQUASOL A
NDA #006823		 SUPPL-19 VITAMIN A PALMITATE CASPER PHARMA LLC Manufacturing (CMC) Approval
09/18/2015 M.V.I.-12 ADULT
NDA #008809		 SUPPL-72 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E HOSPIRA Manufacturing (CMC) Approval
09/18/2015 M.V.I.-12 ADULT
NDA #008809		 SUPPL-72 ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E HOSPIRA Manufacturing (CMC) Approval
09/18/2015 PROGLYCEM
NDA #017425		 SUPPL-16 DIAZOXIDE TEVA BRANDED PHARM Labeling Approval
09/18/2015 PROGLYCEM
NDA #017453		 SUPPL-20 DIAZOXIDE TEVA BRANDED PHARM Labeling Approval
09/18/2015 CLOZARIL
NDA #019758		 SUPPL-74 CLOZAPINE HERITAGE LIFE Labeling Approval
09/18/2015 OPCON-A
NDA #020065		 SUPPL-21 NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE BAUSCH AND LOMB Manufacturing (CMC) Approval
09/18/2015 SABRIL
NDA #020427		 SUPPL-15 VIGABATRIN LUNDBECK PHARMS LLC Labeling Approval
09/18/2015 ALLEGRA ALLERGY
NDA #020872		 SUPPL-36 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
09/18/2015 ALLEGRA HIVES
NDA #020872		 SUPPL-36 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
09/18/2015 CHILDREN'S ALLEGRA ALLERGY
NDA #020872		 SUPPL-36 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
09/18/2015 CHILDREN'S ALLEGRA HIVES
NDA #020872		 SUPPL-36 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
09/18/2015 RELPAX
NDA #021016		 SUPPL-28 ELETRIPTAN HYDROBROMIDE UPJOHN Manufacturing (CMC) Approval
09/18/2015 TEMODAR
NDA #021029		 SUPPL-29 TEMOZOLOMIDE MERCK SHARP DOHME Labeling Approval
09/18/2015 DEPOCYT
NDA #021041		 SUPPL-35 CYTARABINE PACIRA PHARMS INC Manufacturing (CMC) Approval
09/18/2015 SABRIL
NDA #022006		 SUPPL-16 VIGABATRIN LUNDBECK PHARMS LLC Labeling Approval
09/18/2015 BYDUREON
NDA #022200		 SUPPL-20 EXENATIDE SYNTHETIC ASTRAZENECA AB Labeling Approval
09/18/2015 BYDUREON PEN
NDA #022200		 SUPPL-20 EXENATIDE SYNTHETIC ASTRAZENECA AB Labeling Approval
09/18/2015 TOLAK
NDA #022259		 ORIG-1 FLUOROURACIL HILL DERMACEUTICALS Type 5 - New Formulation or New Manufacturer Approval
09/18/2015 TEMODAR
NDA #022277		 SUPPL-9 TEMOZOLOMIDE MERCK SHARP DOHME Labeling Approval
09/18/2015 AFINITOR
NDA #022334		 SUPPL-31 EVEROLIMUS NOVARTIS Efficacy Approval
09/18/2015 DULERA
NDA #022518		 SUPPL-17 FORMOTEROL FUMARATE; MOMETASONE FUROATE ORGANON LLC Manufacturing (CMC) Approval
09/18/2015 TESTOSTERONE ENANTHATE
ANDA #040647		 SUPPL-2 TESTOSTERONE ENANTHATE RISING Labeling Approval
09/18/2015 TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #063081		 SUPPL-35 TOBRAMYCIN SULFATE HOSPIRA Labeling Approval
09/18/2015 TOBRAMYCIN SULFATE
ANDA #063112		 SUPPL-19 TOBRAMYCIN SULFATE HOSPIRA Labeling Approval
09/18/2015 ERYTHROMYCIN AND BENZOYL PEROXIDE
ANDA #065385		 ORIG-1 BENZOYL PEROXIDE; ERYTHROMYCIN LYNE Approval
09/18/2015 SULFASALAZINE
ANDA #075339		 SUPPL-13 SULFASALAZINE NUVO PHARMS INC Labeling Approval
09/18/2015 SULFASALAZINE
ANDA #075339		 SUPPL-14 SULFASALAZINE NUVO PHARMS INC Labeling Approval
09/18/2015 AMLODIPINE BESYLATE
ANDA #077262		 SUPPL-5 AMLODIPINE BESYLATE HIKMA Labeling Approval
09/18/2015 AMLODIPINE BESYLATE
ANDA #078043		 SUPPL-17 AMLODIPINE BESYLATE LUPIN Labeling Approval
09/18/2015 AMLODIPINE BESYLATE
ANDA #078414		 SUPPL-3 AMLODIPINE BESYLATE OXFORD PHARMS Labeling Approval
09/18/2015 AMLODIPINE BESYLATE
ANDA #078414		 SUPPL-7 AMLODIPINE BESYLATE OXFORD PHARMS Labeling Approval
09/18/2015 AMLODIPINE BESYLATE
ANDA #078414		 SUPPL-11 AMLODIPINE BESYLATE OXFORD PHARMS Labeling Approval
09/18/2015 IMIQUIMOD
ANDA #078548		 SUPPL-2 IMIQUIMOD FOUGERA PHARMS Labeling Approval
09/18/2015 IMIQUIMOD
ANDA #078548		 SUPPL-7 IMIQUIMOD FOUGERA PHARMS Labeling Approval
09/18/2015 TESTOSTERONE ENANTHATE
ANDA #085598		 SUPPL-53 TESTOSTERONE ENANTHATE WATSON PHARMS INC Labeling Approval
09/18/2015 CAMPATH
BLA #103948		 SUPPL-5151 ALEMTUZUMAB GENZYME Approval
09/18/2015 LEMTRADA
BLA #103948		 SUPPL-5151 ALEMTUZUMAB GENZYME Approval
09/18/2015 FLUOCINONIDE
ANDA #200735		 SUPPL-1 FLUOCINONIDE FOUGERA PHARMS INC Manufacturing (CMC) Approval
09/18/2015 DEXMEDETOMIDINE HYDROCHLORIDE
ANDA #201072		 ORIG-1 DEXMEDETOMIDINE HYDROCHLORIDE FRESENIUS KABI USA Approval
09/18/2015 JENTADUETO
NDA #201281		 SUPPL-9 LINAGLIPTIN; METFORMIN HYDROCHLORIDE BOEHRINGER INGELHEIM Manufacturing (CMC) Approval
09/18/2015 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #202001		 SUPPL-4 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TORRENT PHARMS LTD Labeling Approval
09/18/2015 PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
ANDA #202001		 SUPPL-5 METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE TORRENT PHARMS LTD Labeling Approval
09/18/2015 LANSOPRAZOLE
ANDA #202319		 SUPPL-12 LANSOPRAZOLE PERRIGO R AND D Labeling Approval
09/18/2015 MARQIBO KIT
NDA #202497		 SUPPL-7 VINCRISTINE SULFATE ACROTECH Manufacturing (CMC) Approval
09/18/2015 BUSPIRONE HYDROCHLORIDE
ANDA #204582		 ORIG-1 BUSPIRONE HYDROCHLORIDE HERITAGE PHARMA Approval
09/21/2015 SUCRAID
BLA #020772		 SUPPL-20 SACROSIDASE QOL MEDCL Approval
09/21/2015 BRILINTA
NDA #022433		 SUPPL-17 TICAGRELOR ASTRAZENECA Labeling Approval
09/21/2015 DOXYCYCLINE HYCLATE
ANDA #062396		 SUPPL-48 DOXYCYCLINE HYCLATE HIKMA INTL PHARMS Labeling Approval
09/21/2015 DOXYCYCLINE HYCLATE
ANDA #062396		 SUPPL-49 DOXYCYCLINE HYCLATE HIKMA INTL PHARMS Labeling Approval
09/21/2015 DOXYCYCLINE HYCLATE
ANDA #062396		 SUPPL-51 DOXYCYCLINE HYCLATE HIKMA INTL PHARMS Labeling Approval
09/21/2015 DOXYCYCLINE HYCLATE
ANDA #062396		 SUPPL-52 DOXYCYCLINE HYCLATE HIKMA INTL PHARMS Labeling Approval
09/21/2015 DOXYCYCLINE HYCLATE
ANDA #062396		 SUPPL-53 DOXYCYCLINE HYCLATE HIKMA INTL PHARMS Labeling Approval
09/21/2015 ERYTHROCIN
ANDA #062638		 SUPPL-30 ERYTHROMYCIN LACTOBIONATE HOSPIRA Labeling Approval
09/21/2015 ERYTHROCIN
ANDA #062638		 SUPPL-31 ERYTHROMYCIN LACTOBIONATE HOSPIRA Labeling Approval
09/21/2015 TOBRAMYCIN SULFATE
ANDA #063111		 SUPPL-18 TOBRAMYCIN SULFATE HOSPIRA Labeling Approval
09/21/2015 CEFPODOXIME PROXETIL
ANDA #065370		 SUPPL-9 CEFPODOXIME PROXETIL AUROBINDO PHARMA Labeling Approval
09/21/2015 CEFPODOXIME PROXETIL
ANDA #065409		 SUPPL-4 CEFPODOXIME PROXETIL AUROBINDO PHARMA LTD Labeling Approval
09/21/2015 CIPROFLOXACIN
ANDA #076558		 SUPPL-35 CIPROFLOXACIN HIKMA Labeling Approval
09/21/2015 CIPROFLOXACIN
ANDA #076558		 SUPPL-36 CIPROFLOXACIN HIKMA Labeling Approval
09/21/2015 CIPROFLOXACIN
ANDA #076558		 SUPPL-38 CIPROFLOXACIN HIKMA Labeling Approval
09/21/2015 CIPROFLOXACIN HYDROCHLORIDE
ANDA #076558		 SUPPL-35 CIPROFLOXACIN HYDROCHLORIDE HIKMA Labeling Approval
09/21/2015 CIPROFLOXACIN HYDROCHLORIDE
ANDA #076558		 SUPPL-36 CIPROFLOXACIN HYDROCHLORIDE HIKMA Labeling Approval
09/21/2015 CIPROFLOXACIN HYDROCHLORIDE
ANDA #076558		 SUPPL-38 CIPROFLOXACIN HYDROCHLORIDE HIKMA Labeling Approval
09/21/2015 GLIPIZIDE AND METFORMIN HYDROCHLORIDE
ANDA #077620		 SUPPL-11 GLIPIZIDE; METFORMIN HYDROCHLORIDE SUN PHARM INDS INC Labeling Approval
09/21/2015 EPLERENONE
ANDA #078482		 SUPPL-4 EPLERENONE CHARTWELL RX Labeling Approval
09/21/2015 GATIFLOXACIN
ANDA #079084		 SUPPL-2 GATIFLOXACIN APOTEX INC Labeling Approval
09/21/2015 ALENDRONATE SODIUM
ANDA #090557		 SUPPL-4 ALENDRONATE SODIUM JUBILANT CADISTA Labeling Approval
09/21/2015 ALENDRONATE SODIUM
ANDA #090557		 SUPPL-6 ALENDRONATE SODIUM JUBILANT CADISTA Labeling Approval
09/21/2015 DULOXETINE HYDROCHLORIDE
ANDA #090728		 SUPPL-3 DULOXETINE HYDROCHLORIDE ZYDUS PHARMS Labeling Approval
09/21/2015 DULOXETINE HYDROCHLORIDE
ANDA #090728		 SUPPL-4 DULOXETINE HYDROCHLORIDE ZYDUS PHARMS Labeling Approval
09/21/2015 ZOLEDRONIC ACID
ANDA #091186		 SUPPL-6 ZOLEDRONIC ACID DR REDDYS LABS LTD Labeling Approval
09/21/2015 IFOSFAMIDE
ANDA #201689		 SUPPL-1 IFOSFAMIDE MYLAN LABS LTD Labeling Approval
09/21/2015 IFOSFAMIDE
ANDA #201689		 SUPPL-3 IFOSFAMIDE MYLAN LABS LTD Labeling Approval
09/21/2015 IFOSFAMIDE
ANDA #201689		 SUPPL-7 IFOSFAMIDE MYLAN LABS LTD Labeling Approval
09/21/2015 CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
ANDA #202440		 ORIG-1 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE PADAGIS ISRAEL Approval
09/21/2015 LETROZOLE
ANDA #202716		 SUPPL-1 LETROZOLE CHARTWELL RX Manufacturing (CMC) Approval
09/21/2015 ESOMEPRAZOLE MAGNESIUM
ANDA #202784		 ORIG-1 ESOMEPRAZOLE MAGNESIUM HETERO LABS LTD III Approval
09/21/2015 DOCETAXEL
NDA #203551		 SUPPL-4 DOCETAXEL ACTAVIS Manufacturing (CMC) Approval
09/21/2015 METHYLTESTOSTERONE
ANDA #204851		 ORIG-1 METHYLTESTOSTERONE IMPAX LABS INC Approval
09/21/2015 TRANEXAMIC ACID
ANDA #205133		 ORIG-1 TRANEXAMIC ACID AUROBINDO PHARMA USA Approval
09/22/2015 AN-SULFUR COLLOID
NDA #017858		 SUPPL-43 TECHNETIUM TC-99M SULFUR COLLOID KIT SUN PHARM INDS INC Manufacturing (CMC) Approval
09/22/2015 SUBUTEX
NDA #020732		 SUPPL-12 BUPRENORPHINE HYDROCHLORIDE INDIVIOR REMS Approval
09/22/2015 SUBOXONE
NDA #020733		 SUPPL-16 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR REMS Approval
09/22/2015 ATNAA
NDA #021175		 SUPPL-28 ATROPINE; PRALIDOXIME CHLORIDE US ARMY Manufacturing (CMC) Approval
09/22/2015 DUODOTE
NDA #021983		 SUPPL-17 ATROPINE; PRALIDOXIME CHLORIDE MMT Manufacturing (CMC) Approval
09/22/2015 SUBOXONE
NDA #022410		 SUPPL-20 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR Efficacy Approval
09/22/2015 SUBOXONE
NDA #022410		 SUPPL-22 BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE INDIVIOR REMS Approval
09/22/2015 VOTRIENT
NDA #022465		 SUPPL-21 PAZOPANIB HYDROCHLORIDE NOVARTIS Labeling Approval
09/22/2015 SPIRONOLACTONE
ANDA #040353		 SUPPL-38 SPIRONOLACTONE ACTAVIS ELIZABETH Labeling Approval
09/22/2015 CEFUROXIME AXETIL
ANDA #065069		 SUPPL-12 CEFUROXIME AXETIL APOTEX Labeling Approval
09/22/2015 CISPLATIN
ANDA #074656		 SUPPL-15 CISPLATIN PHARMACHEMIE BV Labeling Approval
09/22/2015 RISPERIDONE
ANDA #077494		 SUPPL-13 RISPERIDONE PAR PHARM Labeling Approval
09/22/2015 DIVALPROEX SODIUM
ANDA #077567		 SUPPL-11 DIVALPROEX SODIUM MYLAN Labeling Approval
09/22/2015 DIVALPROEX SODIUM
ANDA #077567		 SUPPL-12 DIVALPROEX SODIUM MYLAN Labeling Approval
09/22/2015 DIVALPROEX SODIUM
ANDA #077567		 SUPPL-13 DIVALPROEX SODIUM MYLAN Labeling Approval
09/22/2015 ALA-CORT
ANDA #080706		 SUPPL-12 HYDROCORTISONE CROWN LABS Labeling Approval
09/22/2015 SPIRONOLACTONE
ANDA #089424		 SUPPL-55 SPIRONOLACTONE SUN PHARM INDUSTRIES Labeling Approval
09/22/2015 NARATRIPTAN
ANDA #090288		 SUPPL-9 NARATRIPTAN HYDROCHLORIDE CHARTWELL RX Labeling Approval
09/22/2015 LEVETIRACETAM
ANDA #090461		 SUPPL-1 LEVETIRACETAM BELCHER Labeling Approval
09/22/2015 LEVETIRACETAM
ANDA #090461		 SUPPL-2 LEVETIRACETAM BELCHER Labeling Approval
09/22/2015 LEVETIRACETAM
ANDA #090461		 SUPPL-3 LEVETIRACETAM BELCHER Labeling Approval
09/22/2015 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090781		 SUPPL-3 PRAMIPEXOLE DIHYDROCHLORIDE GLENMARK GENERICS Labeling Approval
09/22/2015 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #090781		 SUPPL-4 PRAMIPEXOLE DIHYDROCHLORIDE GLENMARK GENERICS Labeling Approval
09/22/2015 NARATRIPTAN
ANDA #091552		 SUPPL-2 NARATRIPTAN HYDROCHLORIDE SUN PHARM INDS LTD Labeling Approval
09/22/2015 MYALEPT
BLA #125390		 SUPPL-10 METRELEPTIN AMRYT Approval
09/22/2015 ROPINIROLE HYDROCHLORIDE
ANDA #201047		 SUPPL-8 ROPINIROLE HYDROCHLORIDE SANDOZ INC Labeling Approval
09/22/2015 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202633		 SUPPL-1 PRAMIPEXOLE DIHYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
09/22/2015 PRAMIPEXOLE DIHYDROCHLORIDE
ANDA #202633		 SUPPL-5 PRAMIPEXOLE DIHYDROCHLORIDE AUROBINDO PHARMA LTD Labeling Approval
09/22/2015 OXYCODONE HYDROCHLORIDE
ANDA #202662		 ORIG-1 OXYCODONE HYDROCHLORIDE EPIC PHARMA LLC Approval
09/22/2015 ZOLEDRONIC ACID
ANDA #202837		 SUPPL-3 ZOLEDRONIC ACID HOSPIRA INC Labeling Approval
09/22/2015 BOSULIF
NDA #203341		 SUPPL-3 BOSUTINIB MONOHYDRATE PF PRISM CV Labeling Approval
09/22/2015 CAFFEINE CITRATE
ANDA #205013		 ORIG-1 CAFFEINE CITRATE EUGIA PHARMA Approval
09/22/2015 FLONASE ALLERGY RELIEF
NDA #205434		 SUPPL-2 FLUTICASONE PROPIONATE GLAXOSMITHKLINE CONS Manufacturing (CMC) Approval
09/22/2015 VIEKIRA PAK (COPACKAGED)
NDA #206619		 SUPPL-7 DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR ABBVIE Manufacturing (CMC) Approval
09/22/2015 METHYLPHENIDATE HYDROCHLORIDE
ANDA #207416		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE ASCENT PHARMS INC Approval
09/22/2015 LONSURF
NDA #207981		 ORIG-1 TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE TAIHO ONCOLOGY Type 1 - New Molecular Entity and Type 4 - New Combination Approval
09/23/2015 SOLU-CORTEF
NDA #009866		 SUPPL-90 HYDROCORTISONE SODIUM SUCCINATE PHARMACIA AND UPJOHN Manufacturing (CMC) Approval
09/23/2015 DEPAKENE
NDA #018081		 SUPPL-63 VALPROIC ACID ABBVIE Labeling Approval
09/23/2015 DEPAKENE
NDA #018082		 SUPPL-46 VALPROIC ACID ABBVIE Labeling Approval
09/23/2015 DEPAKOTE
NDA #018723		 SUPPL-55 DIVALPROEX SODIUM ABBVIE Labeling Approval
09/23/2015 DEPAKOTE
NDA #019680		 SUPPL-42 DIVALPROEX SODIUM ABBVIE Labeling Approval
09/23/2015 DEPACON
NDA #020593		 SUPPL-33 VALPROATE SODIUM ABBVIE Labeling Approval
09/23/2015 DEPAKOTE ER
NDA #021168		 SUPPL-32 DIVALPROEX SODIUM ABBVIE Labeling Approval
09/23/2015 ATRIDOX
NDA #050751		 SUPPL-20 DOXYCYCLINE HYCLATE DEN-MAT Manufacturing (CMC) Approval
09/23/2015 MOMETASONE FUROATE
ANDA #076067		 SUPPL-9 MOMETASONE FUROATE PADAGIS US Labeling Approval
09/23/2015 FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ANDA #076837		 SUPPL-7 FLUCONAZOLE DR REDDYS Labeling Approval
09/23/2015 CLOPIDOGREL BISULFATE
ANDA #090494		 SUPPL-5 CLOPIDOGREL BISULFATE SUN PHARM Labeling Approval
09/23/2015 CLOPIDOGREL BISULFATE
ANDA #090494		 SUPPL-6 CLOPIDOGREL BISULFATE SUN PHARM Labeling Approval
09/23/2015 ALENDRONATE SODIUM
ANDA #090520		 SUPPL-2 ALENDRONATE SODIUM HIKMA Labeling Approval
09/23/2015 NEULASTA
BLA #125031		 SUPPL-170 PEGFILGRASTIM AMGEN Approval
09/23/2015 NEULASTA
BLA #125031		 SUPPL-179 PEGFILGRASTIM AMGEN Approval
09/23/2015 NEULASTA
BLA #125031		 SUPPL-181 PEGFILGRASTIM AMGEN Approval
09/23/2015 GAZYVA
BLA #125486		 SUPPL-10 OBINUTUZUMAB GENENTECH Approval
09/23/2015 DIVALPROEX SODIUM
ANDA #202419		 SUPPL-4 DIVALPROEX SODIUM AUROBINDO PHARMA LTD Labeling Approval
09/23/2015 DIVALPROEX SODIUM
ANDA #202419		 SUPPL-5 DIVALPROEX SODIUM AUROBINDO PHARMA LTD Labeling Approval
09/23/2015 DIVALPROEX SODIUM
ANDA #202419		 SUPPL-7 DIVALPROEX SODIUM AUROBINDO PHARMA LTD Labeling Approval
09/23/2015 TOPICORT
NDA #204141		 SUPPL-3 DESOXIMETASONE TARO PHARMS Manufacturing (CMC) Approval
09/23/2015 MIRVASO
NDA #204708		 SUPPL-3 BRIMONIDINE TARTRATE GALDERMA LABS LP Manufacturing (CMC) Approval
09/23/2015 CYPROHEPTADINE HYDROCHLORIDE
ANDA #205087		 ORIG-1 CYPROHEPTADINE HYDROCHLORIDE NOVAST LABS Approval
09/23/2015 METRONIDAZOLE
ANDA #205245		 ORIG-1 METRONIDAZOLE HERITAGE PHARMS INC Approval
09/23/2015 CELECOXIB
ANDA #207446		 ORIG-1 CELECOXIB CIPLA Approval
09/24/2015 ZANTAC 75
NDA #020520		 SUPPL-31 RANITIDINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
09/24/2015 ALLEGRA ALLERGY
NDA #020872		 SUPPL-35 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
09/24/2015 ALLEGRA HIVES
NDA #020872		 SUPPL-35 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
09/24/2015 CHILDREN'S ALLEGRA ALLERGY
NDA #020872		 SUPPL-35 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
09/24/2015 CHILDREN'S ALLEGRA HIVES
NDA #020872		 SUPPL-35 FEXOFENADINE HYDROCHLORIDE CHATTEM SANOFI Manufacturing (CMC) Approval
09/24/2015 REYATAZ
NDA #021567		 SUPPL-38 ATAZANAVIR SULFATE BRISTOL MYERS SQUIBB Efficacy Approval
09/24/2015 CHILDREN'S CLARITIN
NDA #021891		 SUPPL-19 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
09/24/2015 CLARITIN
NDA #021891		 SUPPL-19 LORATADINE BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
09/24/2015 MIRALAX
NDA #022015		 SUPPL-18 POLYETHYLENE GLYCOL 3350 BAYER HEALTHCARE LLC Manufacturing (CMC) Approval
09/24/2015 BYDUREON
NDA #022200		 SUPPL-15 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
09/24/2015 BYDUREON
NDA #022200		 SUPPL-16 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
09/24/2015 BYDUREON
NDA #022200		 SUPPL-17 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
09/24/2015 BYDUREON
NDA #022200		 SUPPL-18 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
09/24/2015 BYDUREON PEN
NDA #022200		 SUPPL-15 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
09/24/2015 BYDUREON PEN
NDA #022200		 SUPPL-16 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
09/24/2015 BYDUREON PEN
NDA #022200		 SUPPL-17 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
09/24/2015 BYDUREON PEN
NDA #022200		 SUPPL-18 EXENATIDE SYNTHETIC ASTRAZENECA AB Efficacy Approval
09/24/2015 ESBRIET
NDA #022535		 SUPPL-1 PIRFENIDONE GENENTECH INC Manufacturing (CMC) Approval
09/24/2015 AMOXIL
NDA #050542		 SUPPL-29 AMOXICILLIN US ANTIBIOTICS Labeling Approval
09/24/2015 AMOXIL
NDA #050754		 SUPPL-19 AMOXICILLIN US ANTIBIOTICS Labeling Approval
09/24/2015 AMOXIL
NDA #050760		 SUPPL-19 AMOXICILLIN US ANTIBIOTICS Labeling Approval
09/24/2015 AMOXIL
NDA #050761		 SUPPL-16 AMOXICILLIN US ANTIBIOTICS Labeling Approval
09/24/2015 CYCLOSPORINE
ANDA #065078		 SUPPL-8 CYCLOSPORINE IVAX SUB TEVA PHARMS Labeling Approval
09/24/2015 CYCLOSPORINE
ANDA #065078		 SUPPL-9 CYCLOSPORINE IVAX SUB TEVA PHARMS Labeling Approval
09/24/2015 CYCLOSPORINE
ANDA #065110		 SUPPL-9 CYCLOSPORINE IVAX SUB TEVA PHARMS Labeling Approval
09/24/2015 CYCLOSPORINE
ANDA #065110		 SUPPL-10 CYCLOSPORINE IVAX SUB TEVA PHARMS Labeling Approval
09/24/2015 ACETAMINOPHEN
ANDA #070607		 SUPPL-8 ACETAMINOPHEN PERRIGO NEW YORK Labeling Approval
09/24/2015 ACETAMINOPHEN
ANDA #070608		 SUPPL-10 ACETAMINOPHEN PERRIGO NEW YORK Labeling Approval
09/24/2015 AMIODARONE HYDROCHLORIDE
ANDA #074739		 SUPPL-34 AMIODARONE HYDROCHLORIDE TEVA PHARMS Labeling Approval
09/24/2015 AMLODIPINE BESYLATE
ANDA #077759		 SUPPL-9 AMLODIPINE BESYLATE UPSHER SMITH LABS Labeling Approval
09/24/2015 CARBIDOPA AND LEVODOPA
ANDA #077828		 SUPPL-8 CARBIDOPA; LEVODOPA SUN PHARM INDS Labeling Approval
09/24/2015 TERBINAFINE HYDROCHLORIDE
ANDA #078163		 SUPPL-7 TERBINAFINE HYDROCHLORIDE ORBION PHARMS Labeling Approval
09/24/2015 TERBINAFINE HYDROCHLORIDE
ANDA #078163		 SUPPL-8 TERBINAFINE HYDROCHLORIDE ORBION PHARMS Labeling Approval
09/24/2015 DONEPEZIL HYDROCHLORIDE
ANDA #090175		 SUPPL-3 DONEPEZIL HYDROCHLORIDE ZYDUS PHARMS USA INC Labeling Approval
09/24/2015 VENLAFAXINE HYDROCHLORIDE
ANDA #090899		 SUPPL-15 VENLAFAXINE HYDROCHLORIDE TORRENT Labeling Approval
09/24/2015 NORETHINDRONE
ANDA #200980		 SUPPL-1 NORETHINDRONE MYLAN LABS LTD Labeling Approval
09/24/2015 DEXMETHYLPHENIDATE HYDROCHLORIDE
ANDA #201231		 ORIG-1 DEXMETHYLPHENIDATE HYDROCHLORIDE SUN PHARM INDUSTRIES Approval
09/24/2015 ZOLEDRONIC ACID
ANDA #201801		 SUPPL-2 ZOLEDRONIC ACID AVET LIFESCIENCES Labeling Approval
09/24/2015 LAMOTRIGINE
ANDA #202383		 SUPPL-3 LAMOTRIGINE DR REDDYS LABS LTD Labeling Approval
09/24/2015 LAMOTRIGINE
ANDA #202383		 SUPPL-6 LAMOTRIGINE DR REDDYS LABS LTD Labeling Approval
09/24/2015 LAMOTRIGINE
ANDA #202383		 SUPPL-7 LAMOTRIGINE DR REDDYS LABS LTD Labeling Approval
09/24/2015 PALIPERIDONE
ANDA #203802		 ORIG-1 PALIPERIDONE RK PHARMA Approval
09/24/2015 TIMOLOL MALEATE
ANDA #204912		 ORIG-1 TIMOLOL MALEATE AKORN INC Tentative Approval
09/24/2015 REYATAZ
NDA #206352		 SUPPL-3 ATAZANAVIR SULFATE BRISTOL MYERS SQUIBB Efficacy Approval
09/25/2015 COMBIVIR
NDA #020857		 SUPPL-30 LAMIVUDINE; ZIDOVUDINE VIIV HLTHCARE Labeling Approval
09/25/2015 LETAIRIS
NDA #022081		 SUPPL-34 AMBRISENTAN GILEAD Manufacturing (CMC) Approval
09/25/2015 ASTEPRO
NDA #022203		 SUPPL-14 AZELASTINE HYDROCHLORIDE MYLAN SPECIALITY LP Manufacturing (CMC) Approval
09/25/2015 DUAVEE
NDA #022247		 SUPPL-2 BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED WYETH PHARMS Labeling Approval
09/25/2015 SOTALOL HYDROCHLORIDE
NDA #022306		 SUPPL-4 SOTALOL HYDROCHLORIDE ALTATHERA PHARMS LLC Manufacturing (CMC) Approval
09/25/2015 AMPICILLIN TRIHYDRATE
ANDA #062882		 SUPPL-12 AMPICILLIN/AMPICILLIN TRIHYDRATE STRIDES PHARMA Labeling Approval
09/25/2015 AMPICILLIN TRIHYDRATE
ANDA #062882		 SUPPL-16 AMPICILLIN/AMPICILLIN TRIHYDRATE STRIDES PHARMA Labeling Approval
09/25/2015 AMPICILLIN TRIHYDRATE
ANDA #062982		 SUPPL-15 AMPICILLIN/AMPICILLIN TRIHYDRATE DAVA PHARMS INC Labeling Approval
09/25/2015 AMLODIPINE BESYLATE
ANDA #076418		 SUPPL-17 AMLODIPINE BESYLATE MYLAN Labeling Approval
09/25/2015 AMLODIPINE BESYLATE
ANDA #076719		 SUPPL-10 AMLODIPINE BESYLATE COREPHARMA Labeling Approval
09/25/2015 TESTOSTERONE
ANDA #076744		 SUPPL-5 TESTOSTERONE STRIDES PHARMA REMS Approval
09/25/2015 OLANZAPINE
ANDA #076866		 SUPPL-3 OLANZAPINE MYLAN Labeling Approval
09/25/2015 OLANZAPINE
ANDA #076866		 SUPPL-4 OLANZAPINE MYLAN Labeling Approval
09/25/2015 TOLTERODINE TARTRATE
ANDA #077006		 SUPPL-1 TOLTERODINE TARTRATE IVAX SUB TEVA PHARMS Manufacturing (CMC) Approval
09/25/2015 RIBAVIRIN
ANDA #077094		 SUPPL-23 RIBAVIRIN ZYDUS PHARMS USA Labeling Approval
09/25/2015 PREDNICARBATE
ANDA #077236		 SUPPL-1 PREDNICARBATE FOUGERA PHARMS Labeling Approval
09/25/2015 AMLODIPINE BESYLATE
ANDA #077771		 SUPPL-4 AMLODIPINE BESYLATE HIKMA PHARMS Labeling Approval
09/25/2015 AMLODIPINE BESYLATE
ANDA #077771		 SUPPL-5 AMLODIPINE BESYLATE HIKMA PHARMS Labeling Approval
09/25/2015 ESOMEPRAZOLE MAGNESIUM
ANDA #078279		 ORIG-1 ESOMEPRAZOLE MAGNESIUM DR REDDYS Approval
09/25/2015 BETASERON
BLA #103471		 SUPPL-5186 INTERFERON BETA-1B BAYER HEALTHCARE PHARMS Approval
09/25/2015 RYZODEG 70/30
BLA #203313		 ORIG-1 INSULIN ASPART; INSULIN DEGLUDEC NOVO Approval
09/25/2015 TRESIBA
BLA #203314		 ORIG-1 INSULIN DEGLUDEC NOVO Approval
09/25/2015 MONTELUKAST SODIUM
ANDA #203582		 SUPPL-1 MONTELUKAST SODIUM MACLEODS PHARMS LTD Manufacturing (CMC) Approval
09/25/2015 OXYCODONE HYDROCHLORIDE
ANDA #204085		 SUPPL-1 OXYCODONE HYDROCHLORIDE CHARTWELL MOLECULAR Manufacturing (CMC) Approval
09/25/2015 ESOMEPRAZOLE SODIUM
ANDA #205379		 ORIG-1 ESOMEPRAZOLE SODIUM ACCORD HLTHCARE Approval
09/25/2015 TRAMADOL HYDROCHLORIDE
ANDA #205702		 ORIG-1 TRAMADOL HYDROCHLORIDE MACLEODS PHARMS LTD Approval
09/27/2015 BUPROPION HYDROCHLORIDE
ANDA #200695		 SUPPL-1 BUPROPION HYDROCHLORIDE SUN PHARM Labeling Approval
09/28/2015 AN-SULFUR COLLOID
NDA #017858		 SUPPL-44 TECHNETIUM TC-99M SULFUR COLLOID KIT SUN PHARM INDS INC Manufacturing (CMC) Approval
09/28/2015 BUMEX
NDA #018225		 SUPPL-25 BUMETANIDE VALIDUS PHARMS Manufacturing (CMC) Approval
09/28/2015 NILANDRON
NDA #020169		 SUPPL-7 NILUTAMIDE CONCORDIA Manufacturing (CMC) Approval
09/28/2015 SANCUSO
NDA #022198		 SUPPL-3 GRANISETRON CUMBERLAND Labeling Approval
09/28/2015 CIPROFLOXACIN HYDROCHLORIDE
ANDA #075593		 SUPPL-20 CIPROFLOXACIN HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
09/28/2015 CIPROFLOXACIN HYDROCHLORIDE
ANDA #075593		 SUPPL-21 CIPROFLOXACIN HYDROCHLORIDE DR REDDYS LABS LTD Labeling Approval
09/28/2015 TIZANIDINE HYDROCHLORIDE
ANDA #076533		 SUPPL-6 TIZANIDINE HYDROCHLORIDE APOTEX Labeling Approval
09/28/2015 TIZANIDINE HYDROCHLORIDE
ANDA #076533		 SUPPL-7 TIZANIDINE HYDROCHLORIDE APOTEX Labeling Approval
09/28/2015 METFORMIN HYDROCHLORIDE
ANDA #077336		 SUPPL-7 METFORMIN HYDROCHLORIDE SUN PHARM INDS (IN) Labeling Approval
09/28/2015 ONDANSETRON
ANDA #077406		 SUPPL-5 ONDANSETRON CHARTWELL MOLECULES Labeling Approval
09/28/2015 TOPOTECAN HYDROCHLORIDE
ANDA #090620		 SUPPL-5 TOPOTECAN HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
09/28/2015 TOPOTECAN HYDROCHLORIDE
ANDA #090620		 SUPPL-6 TOPOTECAN HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
09/28/2015 TOPOTECAN HYDROCHLORIDE
ANDA #090620		 SUPPL-7 TOPOTECAN HYDROCHLORIDE ACTAVIS TOTOWA Labeling Approval
09/28/2015 ROPINIROLE HYDROCHLORIDE
ANDA #090869		 SUPPL-11 ROPINIROLE HYDROCHLORIDE ACTAVIS ELIZABETH Labeling Approval
09/28/2015 TACROLIMUS
ANDA #091195		 SUPPL-5 TACROLIMUS ACCORD HLTHCARE Labeling Approval
09/28/2015 TACROLIMUS
ANDA #091195		 SUPPL-8 TACROLIMUS ACCORD HLTHCARE Labeling Approval
09/28/2015 ILEVRO
NDA #203491		 SUPPL-8 NEPAFENAC HARROW EYE Manufacturing (CMC) Approval
09/28/2015 CLARITHROMYCIN
ANDA #203584		 ORIG-1 CLARITHROMYCIN HEC PHARM Approval
09/28/2015 SODIUM FLUORIDE F-18
ANDA #203890		 ORIG-1 SODIUM FLUORIDE F-18 PETNET Approval
09/28/2015 PIMOZIDE
ANDA #204521		 ORIG-1 PIMOZIDE PAR PHARM Approval
09/28/2015 TRIUMEQ
NDA #205551		 SUPPL-4 ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE VIIV HLTHCARE Labeling Approval
09/29/2015 LACTATED RINGER'S IN PLASTIC CONTAINER
NDA #018921		 SUPPL-31 CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE BAXTER HLTHCARE Labeling Approval
09/29/2015 FRAGMIN
NDA #020287		 SUPPL-63 DALTEPARIN SODIUM PFIZER Labeling Approval
09/29/2015 ESTRING
NDA #020472		 SUPPL-12 ESTRADIOL PFIZER Labeling Approval
09/29/2015 ESTRING
NDA #020472		 SUPPL-13 ESTRADIOL PFIZER Labeling Approval
09/29/2015 CRINONE
NDA #020701		 SUPPL-24 PROGESTERONE ALLERGAN Manufacturing (CMC) Approval
09/29/2015 EPZICOM
NDA #021652		 SUPPL-21 ABACAVIR SULFATE; LAMIVUDINE VIIV HLTHCARE Labeling Approval
09/29/2015 DICLOXACILLIN SODIUM
ANDA #062286		 SUPPL-81 DICLOXACILLIN SODIUM TEVA Labeling Approval
09/29/2015 DICLOXACILLIN SODIUM
ANDA #062286		 SUPPL-82 DICLOXACILLIN SODIUM TEVA Labeling Approval
09/29/2015 CLADRIBINE
ANDA #076571		 SUPPL-6 CLADRIBINE FRESENIUS KABI USA Labeling Approval
09/29/2015 CIPROFLOXACIN HYDROCHLORIDE
ANDA #076639		 SUPPL-11 CIPROFLOXACIN HYDROCHLORIDE UNIQUE Labeling Approval
09/29/2015 CIPROFLOXACIN HYDROCHLORIDE
ANDA #076639		 SUPPL-12 CIPROFLOXACIN HYDROCHLORIDE UNIQUE Labeling Approval
09/29/2015 BUPROPION HYDROCHLORIDE
ANDA #076711		 SUPPL-19 BUPROPION HYDROCHLORIDE IMPAX LABS Labeling Approval
09/29/2015 BUPROPION HYDROCHLORIDE
ANDA #076711		 SUPPL-23 BUPROPION HYDROCHLORIDE IMPAX LABS Labeling Approval
09/29/2015 BUPROPION HYDROCHLORIDE
ANDA #076711		 SUPPL-24 BUPROPION HYDROCHLORIDE IMPAX LABS Labeling Approval
09/29/2015 BUPROPION HYDROCHLORIDE
ANDA #076711		 SUPPL-27 BUPROPION HYDROCHLORIDE IMPAX LABS Labeling Approval
09/29/2015 ALENDRONATE SODIUM
ANDA #090022		 SUPPL-9 ALENDRONATE SODIUM SUN PHARM Labeling Approval
09/29/2015 ALENDRONATE SODIUM
ANDA #090022		 SUPPL-11 ALENDRONATE SODIUM SUN PHARM Labeling Approval
09/29/2015 DASETTA 1/35
ANDA #090948		 SUPPL-1 ETHINYL ESTRADIOL; NORETHINDRONE NOVAST LABS LTD Labeling Approval
09/29/2015 DASETTA 1/35
ANDA #090948		 SUPPL-2 ETHINYL ESTRADIOL; NORETHINDRONE NOVAST LABS LTD Labeling Approval
09/29/2015 WERA
ANDA #091204		 SUPPL-1 ETHINYL ESTRADIOL; NORETHINDRONE NOVAST LABS LTD Labeling Approval
09/29/2015 WERA
ANDA #091204		 SUPPL-2 ETHINYL ESTRADIOL; NORETHINDRONE NOVAST LABS LTD Labeling Approval
09/29/2015 TRANEXAMIC ACID
ANDA #091657		 SUPPL-2 TRANEXAMIC ACID MYLAN INSTITUTIONAL Labeling Approval
09/29/2015 AVASTIN
BLA #125085		 SUPPL-310 BEVACIZUMAB GENENTECH Approval
09/29/2015 METHYLPHENIDATE HYDROCHLORIDE
ANDA #203583		 ORIG-1 METHYLPHENIDATE HYDROCHLORIDE SPECGX LLC Approval
09/29/2015 SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE
ANDA #204591		 ORIG-1 SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE TEVA PHARMS USA INC Tentative Approval
09/29/2015 RILPIVIRINE
ANDA #205302		 ORIG-1 RILPIVIRINE STRIDES ARCOLAB LTD Tentative Approval
09/29/2015 TOUJEO MAX SOLOSTAR
BLA #206538		 SUPPL-1 INSULIN GLARGINE RECOMBINANT SANOFI US SERVICES Approval
09/29/2015 TOUJEO SOLOSTAR
BLA #206538		 SUPPL-1 INSULIN GLARGINE RECOMBINANT SANOFI US SERVICES Approval
09/30/2015 NICORETTE
NDA #018612		 SUPPL-76 NICOTINE POLACRILEX GLAXOSMITHKLINE Labeling Approval
09/30/2015 NICORETTE (MINT)
NDA #018612		 SUPPL-76 NICOTINE POLACRILEX GLAXOSMITHKLINE Labeling Approval
09/30/2015 NICORETTE
NDA #020066		 SUPPL-57 NICOTINE POLACRILEX GLAXOSMITHKLINE Labeling Approval
09/30/2015 NICORETTE (MINT)
NDA #020066		 SUPPL-57 NICOTINE POLACRILEX GLAXOSMITHKLINE Labeling Approval
09/30/2015 EPIVIR
NDA #020564		 SUPPL-35 LAMIVUDINE VIIV HLTHCARE Labeling Approval
09/30/2015 EPIVIR
NDA #020596		 SUPPL-34 LAMIVUDINE VIIV HLTHCARE Labeling Approval
09/30/2015 ZIAGEN
NDA #020977		 SUPPL-30 ABACAVIR SULFATE VIIV HLTHCARE Labeling Approval
09/30/2015 ZIAGEN
NDA #020978		 SUPPL-34 ABACAVIR SULFATE VIIV HLTHCARE Labeling Approval
09/30/2015 OVIDREL
BLA #021149		 SUPPL-40 CHORIOGONADOTROPIN ALFA EMD SERONO Approval
09/30/2015 TRIZIVIR
NDA #021205		 SUPPL-34 ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE VIIV HLTHCARE Labeling Approval
09/30/2015 NICORETTE
NDA #021330		 SUPPL-19 NICOTINE POLACRILEX GLAXOSMITHKLINE CONS Labeling Approval
09/30/2015 FAZACLO ODT
NDA #021590		 SUPPL-28 CLOZAPINE JAZZ Labeling Approval
09/30/2015 LASTACAFT
NDA #022134		 SUPPL-4 ALCAFTADINE ABBVIE Labeling Approval
09/30/2015 NICORETTE
NDA #022360		 SUPPL-10 NICOTINE POLACRILEX GLAXOSMITHKLINE Labeling Approval
09/30/2015 OPDIVO
BLA #125554		 SUPPL-2 NIVOLUMAB BRISTOL MYERS SQUIBB Approval
09/30/2015 DURLAZA
NDA #200671		 SUPPL-2 ASPIRIN ESPERO Labeling Approval
09/30/2015 DEXAMETHASONE SODIUM PHOSPHATE
ANDA #203129		 ORIG-1 DEXAMETHASONE SODIUM PHOSPHATE FRESENIUS KABI USA Approval
09/30/2015 VERSACLOZ
NDA #203479		 SUPPL-9 CLOZAPINE TASMAN PHARMA Labeling Approval
09/30/2015 ZOLMITRIPTAN
ANDA #203772		 ORIG-1 ZOLMITRIPTAN MACLEODS PHARMS LTD Approval
09/30/2015 ADAPALENE AND BENZOYL PEROXIDE
ANDA #203790		 ORIG-1 ADAPALENE; BENZOYL PEROXIDE ACTAVIS MID ATLANTIC Approval
09/30/2015 ARIPIPRAZOLE
ANDA #204094		 ORIG-1 ARIPIPRAZOLE APOTEX Approval
09/30/2015 ZOLMITRIPTAN
ANDA #204232		 ORIG-1 ZOLMITRIPTAN ALEMBIC Approval
09/30/2015 FLONASE ALLERGY RELIEF
NDA #205434		 SUPPL-1 FLUTICASONE PROPIONATE GLAXOSMITHKLINE CONS Labeling Approval
09/30/2015 GLYBURIDE
ANDA #206079		 ORIG-1 GLYBURIDE IMPAX LABS INC Approval
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